MiniMed 780G Insulin Pump Software Anomaly Recall
Medtronic MiniMed's 780G Insulin Pump can stop delivering insulin due to a software anomaly when paired with the Instinct sensor, potentially leading to delayed therapy and increased risk of hyperglycemia or diabetic ketoacidosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a Class II medical device with a software defect that could delay critical insulin therapy and create risk of serious hyperglycemia or diabetic ketoacidosis. No illnesses or injuries have been reported, but the hazard is a known malfunction with potential for significant patient harm.
Plain-English summary
Medtronic MiniMed, Inc. is recalling the MiniMed 780G Insulin Pump (models MMT-1885, MMT-1886, MMT-1895, MMT-1896) due to a software anomaly in version 6.62. The pump can unexpectedly stop delivering insulin when paired with the Instinct sensor. When this occurs, the pump displays two error messages in sequence: Pump Error 53 followed immediately by Pump Error 23.
When insulin delivery stops, patients may experience delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA). The affected devices have been distributed internationally to Spain, Great Britain, Netherlands, and Italy. A total of 778 units are subject to this recall.
Patients currently using the recalled pump models should contact Medtronic MiniMed, Inc. or consult their healthcare provider for guidance on next steps and potential replacement options.
The recalled product
- Product
- MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
- Manufacturer
- Medtronic MiniMed, Inc.
- Hazard
- insulin-delivery-failure
- software-anomaly
- hyperglycemia-risk
- dka-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI/GTIN: A7630006392701
- 00763000521554
- 00763000639273
- A7630006392301
- 00199150035687
- A7630007325603
- A7630007325601
- 00763000639235
- A7630007325604
- 00763000384289
- 00763000521530
- A7630007325401
- 00763000521547
- A7630006392601
- A7630006392201
- 00763000639228
- 00199150035663
- 00763000639266
- A7630007325404
- 00199150035694
Distribution
Distribution scope not specified by the agency.
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